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Partially Replicate Bioequivalence Study of Quetiapine 25 mg in Healthy Volunteers Under Fasting Condition

NCT05235230 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-02-11

No results posted yet for this study

Summary

The current study is conducted to evaluate and compare the relative bioavailability for Quetiapine in two different products containing 25 mg Quetiapine after a single oral dose administration under fasting conditions.

Conditions

  • Bioequivalence

Interventions

DRUG

Test product (T) 25 mg Film Coated Tablets

Film Coated Tablets products containing 25 mg Quetiapine

DRUG

Reference product (R) 25 mg Film Coated Tablets

Reference product (R) 25 mg Film Coated Tablets

Sponsors & Collaborators

  • Future University in Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2021-06-03
Completion
2021-06-03

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05235230 on ClinicalTrials.gov